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Job Description
JOB SUMMARY (Major functions of the position)
The Admin Assistant primarily manages the administrative aspects of clinical trials which includes prepare essential clinical trial documents for ethics and regulatory submission, attend study meeting, coordinate and writing meeting minutes, filing and maintenance of clinical trial related documents, payment tracking and completion. The person will work closely with Study Coordinators (SC) who are supporting Investigators on the good clinical trial conduct at the sites. The person may also work with other study team members including the nurses and Investigators in the hospital.
KEY RESPONSIBILITIES
- Assist in preparation of essential clinical trial documentation including:
– CV, APC and GCP certificate where necessary.
– Export Permit of Human Tissue application via BLESS system. This includes compiling required documents, submission, and collection of the permit at the nearest district health office.
– Update and maintain files on calibration record for equipment that are related to Industry Sponsored Research (ISR).
- Maintain clinical trial tracking systems, by ensuring the data is up-to-date and accurate:
– Update and maintain Investigator database; doctor’s name, therapeutic area, hospital & satellite sites, GCP certification list .
– Assist in feasibility study management, i.e. scan and email the completed feasibility study to relevant study coordinator for their further actions.
– Maintain and update the feasibility log.
– Maintain and update tracker for Site Qualification Visit (SQV) at site.
– Update and maintain files on calibration records for equipment that are related to ISR usage.
– Assist in submission of SCSBF and PIF to CRM finance department. This includes scan, email, and filing the documents in SCMF.
- Monitor study supplies and inventory
– Track, distribute and file relevant study documents
– Manage receival of Investigational Product (IP) and clinical supplies and inform relevant study coordinator.
– Arrange laboratory specimen for vendor’s collection (including bookings and collection).
- Coordinate meetings and writing meeting minutes
– Prepare logistics for meetings or site visit from Sponsors/CROs including but not limited to site selection visit, site initiation visit, site monitoring visit, site closure visits.
– Prepare meeting minutes as per required.
- Perform tasks as delegated by Investigator in accordance to protocol, SOP, GCP and applicable guidelines.
- Perform other administrative duties as assigned.
- Adhere to all Standard Operating Procedures (SOP) and guidelines provided under the ISO 9001:2015 requirements.
- Ensure relevant activities related to Clinical Operations are in line with GCP and ISO standards.
BASIC JOB REQUIREMENTS
- Candidate must possess at least a bachelor’s degree in Science, Life Sciences, clinical research or equivalent
- Computer literacy including MS office (Word, Excel, Powerpoint, Outlook)
- Attention to detail
- Excellent organizational skills
- Good interpersonal skills
- Able to work in a team
